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Manager, System Change & Release Management

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 

The Role

Genmab is looking for a (senior) System Change & Release Manager to help us maintain, develop, and innovate our global electronic document management system (EDMS) – GenDocs, covering document management in the clinical, regulatory, CMC, Quality Assurance areas in Genmab.

GenDocs is a global GxP IT system based on the Veeva Vault cloud platform, and it supports our dynamic and expanding R&D organization. R&D Business Systems Management is a global IT application team consisting of System Managers and Administrators that supports and develops IT GxP systems used in R&D. We continue to develop and innovate business processes in Genmab by implementing new IT features in the systems.  We do this by working closely together with the line of business departments, understanding, and bridging their business needs to the system.

As a (Senior) System Change & Release Manager, you will be responsible for maintaining the overall process and framework for how we align and agree which new changes and releases to be implemented in our GenDocs system. This includes, for example defining and updating our change & release procedure and supporting tools, implementing the core team governance framework for how to align and agree new system changes, train, and facilitate the rest of our team and line of business departments in using the procedure and framework.

You will also be managing software releases from the vendor by conducting risks assessment and testing of the new auto-on IT features, writing newsletters to line of business department, etc. An important part of the role is to be in near contact with the line of business departments to handle their requests for new system changes, aligning expectations and prioritizations. This requires a good combination of IT system knowledge, business process experience, and stakeholder management.

Furthermore, you will participate and contribute to the implementation of system changes to ensure you have a good operational understanding and experience of the GenDocs system.

The position will be part of a smaller team in Copenhagen and will report to the Associate Director, R&D Business Systems Management.


Responsibilities

  • Optimize, develop, and maintain the change & release management procedure and supporting tools

  • Govern the core team set-up and framework by training and facilitating the rest of the team, and line of business participants

  • Participate and support in the preparation and execution of the System Board meetings

  • Liaise with the line of business departments and IT Business Partners to align plans and roadmaps for the future development of the GenDocs system

  • Participate in daily change- or issue-related system maintenance work in the team by doing configuration and system related work

  • Participate during audits and inspections of the GenDocs system

  • Send out formal communication about progression of changes and releases, new features (newsletter, intranet, etc.)

Requirements

  • We expect that you have a bachelor’s degree e.g., Life Science, IT, Engineering, or similar

  • You have at least 7 years of experience in the pharmaceutical or biotech industry. Of which you have a minimum of 3 years experience as a System Manager or similar

  • You have practical work experience with EDMS systems, and preferably Veeva Vault administrator certification

  • It is an advantage but not a requirement if you have worked in clinical development, regulatory affairs, or a similar area within your line of business

  • It is an advantage but not a requirement if you have worked with ServiceNow, or other related ITIL tools

  • You have extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management

  • You have participated in IT GxP projects, either as a project SME, Functional Lead, or Project Manager

  • You have excellent communication skills in both Danish and English, written and oral


Moreover, you meet the following personal requirements:

  • Ability to work independently as well as in teams

  • Service-minded and a good communicator

  • Pragmatic attitude, ability to balance, and see other´s perspective

  • Personal drive, and a positive attitude

  • Detail-oriented, structured, and takes responsibility

 

Degrees of interest: bachelor’s degree e.g., Life Science, IT, Engineering, or similar

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